|
|
522 Order Number |
|
|
|
Manufacturer |
|
|
|
Device Name |
|
|
|
|
Date 522 Order |
|
|
|
Date Original Plan Accepted |
|
|
PS120001
|
Acell, Inc. |
Acell matristem pelvic floor matrix |
General & Plastic Surgery |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
09/08/2013 |
Progress Adequate |
PS140001
|
Argo Medical Technologies, Inc |
Rewalk |
Neurology |
06/26/2014 |
ReWalk Registry
|
05/05/2016 |
Revised/Replaced Study |
ReWalk RWE Study
|
|
Progress Adequate |
PS200001
|
Avenu Medical, Inc. |
Ellipsys vascular access system |
|
01/10/2020 |
Ellipsys Vascular Access System PS Study
|
05/29/2020 |
Study Pending |
PS160001
|
Bayer Healthcare, LLC |
Essure system for permanent birth control |
Obstetrics/ Gynecology |
02/29/2016 |
Postmarket Surveillance Study
|
09/02/2016 |
Progress Adequate |
PS200004
|
Bluegrass Vascular Technologies, Incorporated |
Surfacer inside-out access catheter system |
|
02/10/2020 |
Postmarket Surveillance Study
|
02/22/2021 |
Study Pending |
PS120081
|
Boston Scientific |
Xenform soft tissue repair matrix |
General & Plastic Surgery |
01/03/2012 |
POP AE and Effectiveness rates, registry
|
09/27/2013 |
Progress Adequate |
PS130044
|
Boston Scientific Corporation |
Pinnacle LITE Pelvic Floor Repair Kits - Uphold Lite Posterior and Uphold |
Obstetrics/ Gynecology |
07/03/2013 |
POP AE and Effectiveness rates, registry
|
09/10/2013 |
Progress Adequate |
PS200005
|
Caldera Medical, Inc. |
Desara One Single Incision Sling System |
Gastroenterology/ Urology |
02/11/2020 |
Postmarket Surveillance Study
|
06/05/2020 |
Study Pending |
PS130039
|
Coloplast Corp |
Altis single incision sling system |
Gastroenterology/ Urology |
03/13/2013 |
AE and effectiveness rates
|
12/06/2013 |
Progress Adequate |
PS120106
|
Coloplast Corp. |
Restorelle polypropylene mesh |
General & Plastic Surgery |
04/09/2012 |
POP AE and Effectiveness rates, registry
|
05/17/2013 |
Progress Adequate |
PS150002
|
Fujifilm Medical Systems USA, Inc. |
Fujifilm duodenoscopes |
Gastroenterology/ Urology |
10/05/2015 |
Sampling and Culturing Study
|
12/21/2016 |
Noncompliant |
PS190002
|
FUJIFILM Medical Systems, U.S.A., Inc. |
Duodenoscope |
|
08/28/2019 |
Sampling and Culturing
|
12/06/2019 |
Progress Adequate |
PS110038
|
Johnson and Johnson |
Depuy pinnacle metal-on-metal acetabular cup liners |
Orthopedic |
05/06/2011 |
Explant Analysis
|
07/06/2012 |
Progress Adequate |
PS200006
|
Medtronic, Inc. |
Carpediem |
|
04/29/2020 |
CARPEDIEM 522
|
10/01/2020 |
Study Pending |
PS110070
|
MicroPort |
Metal transcend articulation system |
Orthopedic |
05/06/2011 |
Metal Ion Levels Microport
|
01/30/2017 |
Progress Inadequate |
Explant
|
03/21/2017 |
Progress Inadequate |
Metal Ion Levels Wright
|
11/01/2012 |
Revised/Replaced Study |
PS110002
|
Nexus CMF |
Tmj fossa-eminence/condylar prosthesis system |
Dental |
02/04/2011 |
Registry Database
|
08/23/2013 |
Revised/Replaced Study |
TMJ Fossa-Eminence and Condylar Pros
|
02/04/2011 |
Revised/Replaced Study |
TMJ Registry Study - Total
|
|
Revised/Replaced Study |
TMJM Registry Study - Partial
|
|
Revised/Replaced Study |
Prospective Postmarket Surveillance Study Plan
|
02/04/2011 |
Progress Inadequate |
Explant Analysis Study Plan
|
02/04/2011 |
Progress Adequate |
PS200002
|
Olympus America, Inc. |
Evis exera iii duodenovideoscope tjf-q190v |
Gastroenterology/ Urology |
01/17/2020 |
Human Factors Study
|
06/23/2020 |
Progress Adequate |
PS200003
|
Olympus America, Inc. |
Evis exera iii duodenovideoscope tjf-q190v |
Gastroenterology/ Urology |
01/17/2020 |
Sampling and Culturing Study
|
04/17/2020 |
Progress Adequate |
PS150003
|
Olympus Medical Systems Corporation (OMSC. |
Duodenoscopes |
Gastroenterology/ Urology |
10/05/2015 |
Sampling and Culturing Study
|
11/22/2016 |
Noncompliant |
PS200007
|
Outset Medical Inc. |
Tablo hemodialysis system |
Gastroenterology/ Urology |
06/12/2020 |
Human Factors Study
|
03/05/2021 |
Study Pending |
PS160003
|
Parker Hannifin Corporation |
Indego |
Neurology |
04/15/2016 |
Indego Postmarket Surveillance Study
|
10/07/2016 |
Progress Inadequate |
PS150004
|
Pentax Medical |
Duodenoscopes |
Gastroenterology/ Urology |
10/05/2015 |
Sampling and Culturing Study
|
12/08/2016 |
Progress Adequate |
PS190005
|
Pentax of America, Inc. |
Pentax duodenoscope model ed34-il0t2 |
Gastroenterology/ Urology |
11/15/2019 |
Sampling and Culturing Study
|
02/13/2020 |
Progress Adequate |
PS150001
|
Preceptis |
Hummingbird tympanostomy tube system |
Ear Nose & Throat |
04/23/2015 |
Post-market Surveillance Study (PSS)
|
04/23/2015 |
Progress Inadequate |
PS190001
|
Rapid-Medical, Ltd. |
Comaneci embolization assist device |
|
05/22/2019 |
Success in Comaneci-assist Coils Embolization Surv
|
08/06/2020 |
Progress Adequate |
PS190006
|
Tandem Diabetes Co. |
Control-iq, algorithm |
|
12/13/2019 |
Postmarket Surveillance Study
|
04/30/2020 |
Study Pending |
PS200008
|
Tandem Diabetes Co. |
Control-IQ Technology |
Clinical Chemistry |
06/23/2020 |
PSS
|
|
Plan Pending |
PS110003
|
TMJ Concepts |
Patient-fitted tmj reconstruction prosthesis system |
Dental |
02/04/2011 |
Time to Revision and Explant Analysis
|
01/13/2012 |
Progress Adequate |
PS180002
|
TVA Medical, Inc. |
Everlinq endoavf system |
|
06/22/2018 |
EverlinQ endoAVF
|
11/06/2020 |
Study Pending |